510(k) Report

Devices descending from K030139

40 later devices reach The Cardiop-B System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K072591Cardiop-B System, Version 2.1Paieon, Inc.200738—
+1K060483Volcano Angio-Ivus Mapping (Aim) SystemVolcano Corporation200631—
+2K151780CAAS WorkstationPie Medical Imaging BV20169—
+2K083745The IC-Pro System, Model Version 3.2Paieon, Inc.200930—
+2K073328Cardiop-B System, Version 2.1 with LvaPaieon, Inc.200837—
+3K180019CAAS WorkstationPie Medical Imaging BV20188—
+3K110256The IC-Pro SystemPaieon, Inc.201115—
+3K100292Caas Qva 3D, Caas Qca 3DPie Medical Imaging BV201013—
+3K091781Guided Medical Positioning System (GMPS)Mediguide, Ltd.200911—
+3K092004GE Innova Solid State Xray-Imager Fluoroscopic X-Ray System, Model: 4100IQ, 3100IQ, 2100IQGE Healthcare200902
+3K082907IC-Pro System, Version 3.1.0.4Paieon, Inc.200836—
+4K251355X1-FFRSpectrawave, Inc.20250—
+4K232147CAAS WorkstationPie Medical Imaging BV20241—
+4K182611Qangio XA 3DMedis Medical Imaging Systems BV20194—
+4K133993Caas WorkstationPie Medical Imaging201410—
+4K120282CardnavPaieon, Inc.20120—
+4K120296CPS Direct Mediguide Enabled Outer CatheterSt. Jude Medical, Cardiac Rhythm Management Divisi20121—
+4K120298CPS Excel Mediguide Enabled GuidewireSt. Jude Medical, Cardiac Rhythm Management Divisi20128—
+4K113594C-THV SystemPaieon, Inc.20120—
+4K113076Caas a-ValvePie Medical Imaging BV20121—
+4K100849Sync-RX System, Model AS00010Sync-Rx, Ltd.20104—
+5K243632uWS-Angio BasicShanghai United Imaging Healthcare Co., Ltd.20250—
+5K243769QFR (3.0)Qfr Solutions BV20250—
+5K210093AccuFFRangioArteryFlow Technology Co., Ltd.20212—
+5K190106Intra-Operative Positioning System; Simple Curve Catheter, Reverse Curve Catheter…Centerline Biomedical, Inc.20196Class I
+5K143044CAAS A-ValvePie Medical Imaging BV20150—
+5K142239CPS Direct MediGuide Enabled outer catheterSt Jude Medical20140—
+5K142254CPS Excel MediGuide Enabled Guidewire, CPS Excel MediGuide Torque clip, CPS Excel…St Jude Medical20140—
+5K132558Sync-RX SystemVolcano Corporation201331
+6K243842Intra-Operative Positioning System (IOPS®)Centerline Biomedical, Inc.20252Class I
+6K242133Intra-Operative Positioning System (IOPS®) (Fiducial Tracking Pad); Intra-Operative…Centerline Biomedical, Inc.20243Class I
+6K241243Intra-Operative Positioning System (IOPS®) Viewpoint (Simple Curve Catheters)…Centerline Biomedical, Inc.20243Class I
+6K230309Intra-Operative Positioning System (IOPS®) (MC-1); IOPS Simple Curve Catheter (SCC-1)…Centerline Biomedical, Inc.20235Class I
+6K230303AccuFFRangio PlusArteryFlow Technology Co., Ltd.20230—
+6K221711AccuICASArteryFlow Technology Co., Ltd.20230—
+6K151904SyncVision SystemVolcano Corporation201521
+7K261329Intra-Operative Positioning System (IOPS) (MC-1);IOPS Viewpoint Simple Curve Catheter…Centerline Biomedical20260—
+7K254089IOPS Visionary System (MC-3); IOPS Viewpoint Simple Curve Catheter, 75cm (C00751); IOPS…Centerline Biomedical, Inc.20260—
+7K161756SyncVision SystemVolcano Corporation201611
+8K172574SyncVision SystemVolcano Corporation201701